The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Boehringer Mannheim C.f.a.s. - Hdl/ldl-c-plus.
| Device ID | K974825 |
| 510k Number | K974825 |
| Device Name: | BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Edward R Kimmelman |
| Correspondent | Edward R Kimmelman BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-24 |
| Decision Date | 1998-01-30 |
| Summary: | summary |